FDA Medical devices recall ·
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port recall
- Recall number
- Z-0353-2026
- Date
- (initiated September 8, 2025)
- Company / brand
- ICU Medical, Inc.
951 Calle Amanecer, San Clemente, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 6450 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
Why was it recalled?
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI:10887709071411/Lot:14386086 14407433
Distribution
Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.
States: Alaska Arkansas Arizona California Connecticut Florida Georgia Iowa Illinois Kansas Kentucky Maryland Michigan Minnesota Mississippi Montana North Carolina Nebraska New Jersey New Mexico Nevada New York South Dakota Tennessee Texas Virginia Washington Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0353-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.